Atorvastatin Calcium
Product Images NDC 43353-983

6 FDA label images from Aphena Pharma Solutions - Tennessee, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Atorvastatin Calcium (NDC 43353-983). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aphena Pharma Solutions - Tennessee, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Bottle Label 80mg (43353 0983 30)

Bottle Label 80mg (43353 0983 30)
Label for Atorvastatin Calcium 80mg tablets, containing 30 tablets per bottle. The label includes storage instructions (20-25°C), repackaging information by Aphena Pharma Solutions - Tennessee, LLC, and original manufacturing by Kremers Urban Pharmaceuticals Inc., Princeton, NJ. The label also shows NDC number 43353-0983-30 and RX only designation.*
FDA Label Image

Aphena Pharma Solutions (TN)

FDA Label Image

Chemical Structure (Atorvastatin 01)

Chemical Structure (Atorvastatin 01)
Chemical structure of Atorvastatin Calcium, showing its molecular arrangement including rings and functional groups, with details of calcium ion and hydration indicated.*
FDA Label Image

Figure 1 (Atorvastatin 02)

Figure 1 (Atorvastatin 02)
A cumulative incidence line graph comparing Atorvastatin versus placebo over a 3.5-year period. The y-axis represents cumulative incidence in percentage, while the x-axis shows years. Two lines depict the incidence for Atorvastatin (solid line) and placebo (dashed line), indicating a lower incidence rate for Atorvastatin throughout the timeframe.*
FDA Label Image

Figure 2 (Atorvastatin 03)

Figure 2 (Atorvastatin 03)
A line chart depicting the cumulative hazard percentage over four years of follow-up for Atorvastatin compared to placebo. The x-axis represents time in years to the first primary endpoint, while the y-axis shows cumulative hazard percentage. Atorvastatin shows a lower cumulative hazard compared to placebo, with a hazard ratio of 0.63 (95% CI: 0.48-0.83) and a significance level of p=0.001.*
FDA Label Image

Figure 3 (Atorvastatin 04)

Figure 3 (Atorvastatin 04)
A line graph comparing the percentage of subjects experiencing a major cardiovascular event over time between Atorvastatin 10 mg and Atorvastatin 80 mg dosages. The x-axis represents time to first major cardiovascular endpoint in years, and the y-axis represents the percentage of subjects experiencing the event. The graph includes hazard ratio and p-value statistics.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.